PREZISTA TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

DARUNAVIR (DARUNAVIR ETHANOLATE)

Pieejams no:

JANSSEN INC

ATĶ kods:

J05AE10

SNN (starptautisko nepatentēto nosaukumu):

DARUNAVIR

Deva:

150MG

Zāļu forma:

TABLET

Kompozīcija:

DARUNAVIR (DARUNAVIR ETHANOLATE) 150MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

240

Receptes veids:

Prescription

Ārstniecības joma:

HIV PROTEASE INHIBITORS

Produktu pārskats:

Active ingredient group (AIG) number: 0151656005; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2011-07-07

Produkta apraksts

_Non Ann PM PRZ SNDS 268362 02232023.docx _
_EDMS-RIM-841119 v8.0 _
_ _
_Page 1 of 93_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PREZISTA
®
darunavir tablets 75 mg, 150 mg, 600 mg, 800 mg
darunavir oral suspension 100 mg/mL
(as darunavir ethanolate)
Human Immunodeficiency Virus (HIV) Protease Inhibitor
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Initial Authorization:
July 27, 2006
Date of Revision:
March 3, 2023
Submission Control Number: 268362
© 2023 Janssen Inc.
All trademarks used under license
_Non Ann PM PRZ SNDS 268362 02232023.docx _
_EDMS-RIM-841119 v8.0 _
_ _
_Page 2 of 93_
_ _
RECENT MAJOR LABEL CHANGES
None at the time of the most recent authorization
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
RECENT MAJOR LABEL CHANGES
......................................................................................
2
TABLE OF CONTENTS
...........................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
...........................................................................................................
4
1.2
Geriatrics
...........................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
..............................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................... 5
4.5
Missed Dose
........